Research in the Schools: Working with the IRB Lisa M. Abrams, Ph.D. VCU IRB Panel B Assistant Professor, School of Education, Foundations Department Ann S. Allen, Ph.D. VCU IRB Panel B Coordinator, Research & Evaluation, Richmond City Public Schools Monika S. Markowitz, Ph.D.
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Research in the Schools: Working with the IRB
Lisa M. Abrams, Ph.D.
VCU IRB Panel B
Assistant Professor, School of Education, Foundations Department
Ann S. Allen, Ph.D.
VCU IRB Panel B
Coordinator, Research & Evaluation, Richmond City Public Schools
Monika S. Markowitz, Ph.D.
Director, Office of Education and Compliance Oversight
Vice President’s Office for Research
Virginia Commonwealth University
privacy & confidentiality
Federal Regulations and Policy stemming from Belmont Principles
45 CFR 46 – DHHS Policy for Protection of Human Research Subjects- Subpart A
Originally adopted January 13, 1981
Revised June 18, 1991
“The Common Rule” – adopted by 17 federal agencies, including FDA regulated research in 1991
A systematic investigation designed to develop or contribute to generalizable knowledge.
45 CFR 46.102(d)
A living individual about whom an investigator…conducting research obtains
1) data through intervention or interaction with the individual, or
2) identifiable private information
45 CFR 46.102(f)
‘Systematic’: use of statistical analyses, scientific methods – can include ‘nonresearch’
What about ‘generalizable’ ?
- Is the intent of this project to contribute to knowledge in the
field or discipline?
- Are there hypotheses or research questions?
- Will analysis of data lead to generalizable claims, inform policy?
- Is there an intent to publish or present the project as research?
If ‘yes’ >>>>> the project is research
OHRP Guidance Chart 1: Is an Activity Research Involving Human Subjects Covered by 45CFR part 46?
Find information at VCU IRB website at:
Activities Needing IRB Approval
VCU WPP II-2 Determining what constitutes human research
Source: Family Policy Compliance Office (FPCO)
FERPA gives parents certain rights with respect to their children's education records.
These rights transfer to the student when he or she reaches the age of 18 or attends a school beyond the high school level. Students to whom the rights have transferred are "eligible students."
Schools must have written permission from the parent or eligible student in order to release any information from a student's education record.
However, FERPA allows schools to disclose those records, without consent, in nine (9) limited areas (34 CFR § 99.31):
School officials with legitimate educational interest;
Specified officials for audit or evaluation purposes;
Organizations conducting certain studies for or on behalf of the school;
The law requires that schools obtain written consent from parents before minor students are required to participate in any U.S. Department of Education funded survey, analysis, or evaluation that reveals information concerning the following areas:
Mental and psychological problems
Sex behavior and attitudes;
Illegal, anti-social, self-incriminating and demeaning behavior;
Critical appraisals of family;
Legally recognized privileged relationships (i.e.,lawyers, physicians, and ministers);
Religious practices or beliefs; or
Type of IRB Review
Parental Opt Out (if permitted by the school division)
never see the ‘opt out’ information letter which their children are asked to bring home, parental permission or lack of permission cannot be presumed).
Parental ‘Opt In’ may be required
Check division policies before designing your study
Parental permission, waiver, documentation of permission
permission (often described as an ‘opt in’ process by the school
divisions), describe how parental permission/non-permission will
be tracked and how corresponding students will be identified.
Engagement of non-VCU institutions
(FWA’s are in process for local school divisions).
- Indicate whether the school/division is “engaged” in the research. Describe the role of the school/school district and its personnel. (It may be possible to ‘disengage’ school personnel).
- If “engaged” and Federally-funded, provide the OHRP
YES, if employees or agents:
intervene with living individuals by manipulating the environment for research purposes
interact with living individuals for research purposes
release individually identifiable private information, or permit investigators to obtain individually identifiable private information, without subjects' explicit written permission
NO, if employees or agents:
inform prospective subjects about the availability of research;
provide prospective subjects with written information about research (which may include a copy of the relevant informed consent document and other IRB-approved materials) but do not obtain subjects' consent or act as authoritative representatives of the investigators;
provide prospective subjects with information about contacting investigators for information or enrollment;
obtain and appropriately document prospective subjects' permission for investigators to contact them.
Engagement of non-VCU institutions and training
Provide the IRB with info about the qualifications of personnel who will be involved or engaged. Describe the ‘who’ and ‘what’ for training about the protocol.
training ‘engaged’ school personnel about human
subjects protection. The alternative plan for
training must be approved by the IRB.
Readability of parental information
Endorsement of the research by the school district
investigator(s)’s name and contact info should appear on
the letter together with the name of the school/division’s
Describe school-imposed constraints and requirements
Be aware of IRB constraints and requirements
Remember: The IRB review is highly dependent on the quality of the submission. Carefully address instructions and provide thorough, well-organized information.